Diagnostic Accuracy of NICE Classification to Predict Deep Submucosal Invasion - Clinical Trial for Colonic Polyps | NCT02328066

Back to results

Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

NBI used by trained endoscopists

About this trial

This is an interventional diagnostic trial for Colonic Polyps focused on measuring NBI, NICE classification, deep submucosal invasion, Colonic Polyps [C23.300.825.411.235], Colonoscopy [E01.370.372.250.250.200]

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion patients criteria:

Patients> 18 years
Lesion Type 0 of Paris classification, greater than 1 cm, found in a colonoscopy performed by any medical indication with a high definition endoscope with Narrow Band Imaging.
Achievable histology by endoscopic or surgical resection.
Writing informed consent given.

Exclusion patients criteria:

Age <18 years.
Refusal to give informed consent.
Contraindication for endoscopic or surgical resection.
Urgent colonoscopy indication (eg severe rectorrhagia.).
Patients with inflammatory bowel disease.
Suspected metastatic neoplasia by previous imaging tests.

Exclusion lesions criteria:

Polyp previously biopsied or resected.
Poor preparation that does not allow a proper assessment of the lesion.
NBI not performed.
Unavailable or indefinite histology (endoscopic or surgical resection).

Sites / Locations

Ignasi Puig

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NBI used by trained endoscopists

Arm Description

Assessment with NICE classification and NBI technology of colonic lesions (Paris classification type 0) greater than 1 cm found in a routine colonoscopy. This assessment was performed by previously trained endoscopists.

Outcomes

Primary Outcome Measures

Diagnostic accuracy of NICE classification to predict deep submucosal invasion

Sensibility, specificity, negative predictive value and positive predictive value of NICE classification to predict deep submucosal invasion during routine colonoscopies. Gold standard (histology): positive means adenocarcinoma with deep submucosal invasion (>1 mm) negative means non adenocarcinoma or superficial adenocarcinoma (<1 mm) Evaluated test (NICE classification): Positive means NICE type 3. Negative means NICE type 1 and 2. Evaluated test (NICE classification) was blinded to the pathologist who performed the gold standard test (histology)

Secondary Outcome Measures

Diagnostic accuracy of NICE classification to predict deep submucosal invasion in the pre-learning test

Sensibility, specificity, negative predictive value and positive predictive value of NICE classification to predict deep submucosal invasion in the pre-learning test.

Diagnostic accuracy of NICE classification to predict deep submucosal invasion in the post-learning test

Sensibility, specificity, negative predictive value and positive predictive value of NICE classification to predict deep submucosal invasion in the post-learning test (pre-clinical test)

Preplanned potential factors that could influence diagnostic accuracy of NICE classification

Related to the lesion: Size (mm); location: rectum/sigmoid/left colon/splenic flexure/transverse colon/hepatic flexure/right colon and cecum; Morphology according to the Paris classification (see categories in the reference article); Level of confidence: high/low; Successful complete submucosal injection: yes/no/not done; Chicken skin's sign: yes/no; Edges retraction: yes/no; Depressed areas: yes/no; Folds convergence: yes/no; Induration: yes/no; Obvious ulceration: yes/no; Polyp on polyp: yes/no; Technical resection: 8 categories according to the current practice. Related to the equipment: Colonoscope: 11 colonoscope models; Videoprocessor: Exera II, Exera III; Monitor: high definition, non-high definition Related to the endoscopist: Hospital type: Secondary or tertiary; Endoscopy experience (number of years); Previous experience in chromoendoscopy: yes/no; Previous experience in NBI: yes/no; Number of lesions included in the study; Review histology and images monthly: yes/no

Histological predictors of lymph node metastases of pT1

Histological type: adenocarcinoma, mucinous adenocarcinoma, cell carcinoma with signet ring, undifferentiated carcinoma, other. Histologic Grade: Low Grade (well-moderately differentiated) or High-grade (poorly dif, undifferentiated, mucinous, signet ring). Horizontal size of adenocarcinoma (mm) Level of submucosal adenocarcinoma (mm) Angiolymphatic invasion of small vessels: Present or absent Perineural invasion: Present or Absent. Tumor budding: Absent, Low grade (5-9 groups of 5 cells per field with 20x objective), High Grade (≥10 groups of 5 cells per field with 20x objective) Polyp type that originated carcinoma: Tubular adenoma, Villous adenoma, Adenoma/sessile serrated polyp, Traditional serrated adenoma, Other Resection margin: Negative or Positive Size of negative margin (mm).

Full Information

NCT ID

NCT02328066

First Posted

December 8, 2014

Last Updated

June 26, 2018

Sponsor

Asociación Española de Gastroenterología

1. Study Identification

Unique Protocol Identification Number

NCT02328066

Brief Title

Diagnostic Accuracy of NICE Classification to Predict Deep Submucosal Invasion

Acronym

NICE

Official Title

Diagnostic Accuracy of NICE Classification to Predict Deep Submucosal Invasion in Colon Lesions. Prospective Multicenter Study in Routine Clinical Practice

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Completed

Study Start Date

July 2014 (undefined)

Primary Completion Date

July 2016 (Actual)

Study Completion Date

July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Asociación Española de Gastroenterología

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

The purpose of this study is to evaluate the diagnostic accuracy of NICE classification to predict deep submucosal invasion of colonic polyps > 1 cm, considering histology as the gold standard, in a group of endoscopists who previously performed a training program.

Detailed Description

In the first phase of the study, a learning program of NICE classification based on examples will be performed. Forty images will be evaluated before and after the learning program. In the second phase of the study, all consecutive patients who underwent to a colonoscopy will be included if a lesion greater than 1 cm is found and the endoscopy is performed with a high definition colonoscope with Narrow Band Imaging (NBI). Patients, lesions and endoscopy equipment characteristics will be recorded. Subsequently, histological diagnosis of the lesion will also be recorded. Evaluated test (NICE classification) was blinded to the pathologist who performed the gold standard test (histology). In case of adenocarcinomas, histological predictors of lymph node metastases, with predefined assessment criteria, will also be recorded. Finally, histological preparations of adenocarcinomas will be sent to the reference center and two experienced pathologists will examine them again.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colonic Polyps

Keywords

NBI, NICE classification, deep submucosal invasion, Colonic Polyps [C23.300.825.411.235], Colonoscopy [E01.370.372.250.250.200]

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

2171 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NBI used by trained endoscopists

Arm Type

Experimental

Arm Description

Assessment with NICE classification and NBI technology of colonic lesions (Paris classification type 0) greater than 1 cm found in a routine colonoscopy. This assessment was performed by previously trained endoscopists.

Intervention Type

Device

Intervention Name(s)

NBI used by trained endoscopists

Other Intervention Name(s)

Narrow Band Imaging, NICE classification

Intervention Description

Examination of colon lesions, using NBI and NICE classification, by endoscopists who previously performed an easy learning program. The learning program consists on the reading of two reference articles and a tutorial explaining the NICE classification. This tutorial shows several lesions and describes the characteristic features in which the classifications focus on.

Primary Outcome Measure Information:

Title

Diagnostic accuracy of NICE classification to predict deep submucosal invasion

Description

Sensibility, specificity, negative predictive value and positive predictive value of NICE classification to predict deep submucosal invasion during routine colonoscopies. Gold standard (histology): positive means adenocarcinoma with deep submucosal invasion (>1 mm) negative means non adenocarcinoma or superficial adenocarcinoma (<1 mm) Evaluated test (NICE classification): Positive means NICE type 3. Negative means NICE type 1 and 2. Evaluated test (NICE classification) was blinded to the pathologist who performed the gold standard test (histology)

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Diagnostic accuracy of NICE classification to predict deep submucosal invasion in the pre-learning test

Description

Sensibility, specificity, negative predictive value and positive predictive value of NICE classification to predict deep submucosal invasion in the pre-learning test.

Time Frame

0

Title

Diagnostic accuracy of NICE classification to predict deep submucosal invasion in the post-learning test

Description

Sensibility, specificity, negative predictive value and positive predictive value of NICE classification to predict deep submucosal invasion in the post-learning test (pre-clinical test)

Time Frame

0

Title

Preplanned potential factors that could influence diagnostic accuracy of NICE classification

Description

Related to the lesion: Size (mm); location: rectum/sigmoid/left colon/splenic flexure/transverse colon/hepatic flexure/right colon and cecum; Morphology according to the Paris classification (see categories in the reference article); Level of confidence: high/low; Successful complete submucosal injection: yes/no/not done; Chicken skin's sign: yes/no; Edges retraction: yes/no; Depressed areas: yes/no; Folds convergence: yes/no; Induration: yes/no; Obvious ulceration: yes/no; Polyp on polyp: yes/no; Technical resection: 8 categories according to the current practice. Related to the equipment: Colonoscope: 11 colonoscope models; Videoprocessor: Exera II, Exera III; Monitor: high definition, non-high definition Related to the endoscopist: Hospital type: Secondary or tertiary; Endoscopy experience (number of years); Previous experience in chromoendoscopy: yes/no; Previous experience in NBI: yes/no; Number of lesions included in the study; Review histology and images monthly: yes/no

Time Frame

1 year

Title

Histological predictors of lymph node metastases of pT1

Description

Histological type: adenocarcinoma, mucinous adenocarcinoma, cell carcinoma with signet ring, undifferentiated carcinoma, other. Histologic Grade: Low Grade (well-moderately differentiated) or High-grade (poorly dif, undifferentiated, mucinous, signet ring). Horizontal size of adenocarcinoma (mm) Level of submucosal adenocarcinoma (mm) Angiolymphatic invasion of small vessels: Present or absent Perineural invasion: Present or Absent. Tumor budding: Absent, Low grade (5-9 groups of 5 cells per field with 20x objective), High Grade (≥10 groups of 5 cells per field with 20x objective) Polyp type that originated carcinoma: Tubular adenoma, Villous adenoma, Adenoma/sessile serrated polyp, Traditional serrated adenoma, Other Resection margin: Negative or Positive Size of negative margin (mm).

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion patients criteria: Patients> 18 years Lesion Type 0 of Paris classification, greater than 1 cm, found in a colonoscopy performed by any medical indication with a high definition endoscope with Narrow Band Imaging. Achievable histology by endoscopic or surgical resection. Writing informed consent given. Exclusion patients criteria: Age <18 years. Refusal to give informed consent. Contraindication for endoscopic or surgical resection. Urgent colonoscopy indication (eg severe rectorrhagia.). Patients with inflammatory bowel disease. Suspected metastatic neoplasia by previous imaging tests. Exclusion lesions criteria: Polyp previously biopsied or resected. Poor preparation that does not allow a proper assessment of the lesion. NBI not performed. Unavailable or indefinite histology (endoscopic or surgical resection).

Overall Study Officials: